Existing law, the Medical Waste Management Act, regulates the disposal of medical waste, including requiring medical waste to be treated by specified methods prior to disposal, including incineration in a controlled-air, multichamber incinerator, or other method of incineration approved by the State Department of Public Health that provides complete combustion of the waste into carbonized or mineralized ash.

This bill would include among those authorized treatment methods any alternative medical waste treatment solely designed to treat pharmaceutical waste, including a pharmaceutical incinerator, as defined, and would require this method to be evaluated and approved by the State Department of Public Health. The bill would require the department to complete the first evaluation and approval of these alternative medical waste treatments solely designed to treat pharmaceutical waste, including a pharmaceutical incinerator, by June 1, 2017. 2017, and would require the department to consult with specified entities, including the Department of Toxic Substances Control and the State Air Resources Board, in the evaluation to ensure compliance with all other applicable environmental quality laws. The bill would authorize a law enforcement agency that operates a prescription drug takeback program to utilize a pharmaceutical incinerator up to 4 times per year if the incinerator is evaluated and approved by the department. department and complies with all other applicable federal and state laws and local ordinances.

Existing law, the Medical Waste Management Act, regulates the disposal of medical waste, including requiring medical waste to be treated by specified methods prior to disposal, including incineration in a controlled-air, multichamber incinerator, or other method of incineration approved by the State Department of Public Health that provides complete combustion of the waste into carbonized or mineralized ash.

This bill would include among those authorized treatment methods any alternative medical waste treatment solely designed to treat pharmaceutical waste, including a pharmaceutical incinerator, as defined, and would require this method to be evaluated and approved by the State Department of Public Health. The bill would require the department to complete the first evaluation and approval of these alternative medical waste treatments solely designed to treat pharmaceutical waste, including a pharmaceutical incinerator, by June 1, 2017. The bill would authorize a law enforcement agency that operates a prescription drug takeback program to utilize a pharmaceutical incinerator up to 4 times per year if the incinerator is evaluated and approved by the department.

Existing law, the Medical Waste Management Act, regulates the disposal of medical waste, including requiring medical waste to be treated by specified methods, methods prior to disposal, including incineration in a controlled-air, multichamber incinerator, or other method of incineration approved by the department State Department of Public Health that provides complete combustion of the waste into carbonized or mineralized ash.

This bill would include among those authorized treatment methods any alternative medical waste treatment solely designed to treat pharmaceutical waste, including a pharmaceutical incinerator, as defined, and would require this method to be evaluated and approved by the State Department of Public Health. The bill would authorize a law enforcement agency that operates a prescription drug takeback program to utilize a prescription drug pharmaceutical incinerator that does not comply with state law up to 4 times per year if the incinerator was purchased prior to January 1, 2018. is evaluated and approved by the department.

Existing law, the Medical Waste Management Act, regulates the disposal of medical waste, including requiring medical waste to be treated by specified methods, including incineration in a controlled-air, multichamber incinerator, or other method of incineration approved by the department that provides complete combustion of the waste into carbonized or mineralized ash.

This bill would authorize a law enforcement agency that operates a prescription drug takeback program to utilize a prescription drug incinerator that does not comply with state law up to 4 times per year if the incinerator was purchased prior to January 1, 2018.

SENATE COMMITTEE ON APPROPRIATIONS

Senator Ricardo Lara, Chair

2015 - 2016 Regular Session

AB 649 (Patterson) - Medical waste: law enforcement drug takeback programs

This bill meets the criteria for referral to the Suspense File.

Bill Summary:

AB 649 would require Department of Public Health (DPH) to evaluate and approve an alternative medical waste treatment method that is designed to treat pharmaceutical waste by June 1, 2017 and would limit the use of such a technology by a law enforcement agency.

Fiscal Impact:

• Potential unknown one-time costs, ranging from the thousands to hundreds of thousands, to the Medical Waste Management Fund (special fund) if the first alternative medical waste treatment technology evaluation needs to be expedited to comply with the June 1, 2017 deadline.

• Unknown costs, potentially in the hundreds of thousands, to the Medical Waste Management Fund (special fund) for DPH to consult with other agencies on compliance with applicable environmental quality laws.

Background:

Pursuant to the Medical Waste Management Act, DPH regulates the management and handling of medical waste and authorizes off-site medical waste treatment facilities, oversees transfer stations, approves alternative treatment technologies, and acts as the local law enforcement agency in 25 jurisdictions where local agencies have elected not to conduct their own enforcement.

Approval of alternative medical waste treatment methods is subject to the criteria specified in subdivision (a) of §118215 of the Health and Safety Code.

Proposed Law:

This bill would require DPH to evaluate and approve any alternative medical waste treatment solely designed to treat pharmaceutical waste, including a pharmaceutical incinerator. DPH would be required to complete its first evaluation by June 1, 2017. DPH would also be required to consult with the State Water Resources Control Board (SWRCB), the Department of Toxic Substances Control (DTSC), the State Air Resources Board (ARB), and local air quality management districts to ensure compliance with all other environmental laws prior to approval of the alternative treatment.

This bill would also prohibit a law enforcement agency that operates a prescription drug takeback program from utilizing a pharmaceutical incinerator more than four times a year.

Staff Comments:

DPH has existing authority to approve alternative medical waste treatments. This bill does not alter this authority other than establish a deadline for the first evaluation of a technology that is solely designed to treat pharmaceuticals. The deadline of June 1, 2017 is irrespective of when, and if, an application for such a technology may be received. The time necessary to evaluate a technology can vary widely depending on the type of technology as well as the quality of the data submitted with the application. Should the first application be received with insufficient time before the deadline to evaluate the technology under the existing process, this bill would require DPH to expedite the evaluation at an unknown cost.

Staff notes that under the existing evaluation process in which there are no time limitations, DPH can have evaluation costs that are not offset by the application fee. These costs can exceed the application fee by thousands to hundreds of thousands of dollars. These costs are not attributable to this bill as the bill does not change what must be evaluated, only the timeline in which it must be done.

This bill would require DPH to consult with the SWRCB, DTSC, and ARB prior to approval of an alternative medical waste treatment technology. Under the existing approval process, it is the responsibility of the applicant to provide DPH with proof that they have received the appropriate approvals from other agencies that may have regulatory jurisdiction. This bill appears to shift the onus onto DPH. As such, this bill may increase the costs to evaluate a technology to include coordination with other agencies regarding their approval.

This bill would allow a law enforcement agency operating a prescription drug takeback program to utilize a pharmaceutical incinerator that has been approved by DPH up to four times a year. Under existing law, to use a pharmaceutical incinerator, the law enforcement agency would be required to obtain a permit from DPH. This bill does not alter this requirement; however, the issued permit would have to have a special condition to limit the use of the incinerator. To issue a permit with such a condition can be done without changing DPH’s administrative costs. However, staff notes that it is unclear how DPH would enforce such a use limitation or why such a limitation is necessary if law enforcement agency is using an approved technology.

-- END --

SENATE COMMITTEE ON ENVIRONMENTAL QUALITY

Senator Wieckowski, Chair

2015 - 2016 Regular

Bill No: AB 649

SUBJECT: Medical waste: law enforcement drug takeback programs.

ANALYSIS:

Existing law:

1. Exempts household pharmaceutical waste from hazardous waste classifications (40 CFR 261.4(b)) and as medical waste. (Health and Safety Code §117700)

2. Pursuant to the Medical Waste Management Act (MWMA), requires the California Department of Public Health (DPH) to regulate the management and handling of medical waste and authorizes off-site medical waste treatment facilities, oversees transfer stations, approves alternative treatment technologies, and acts as the local enforcement agency in 25 jurisdictions where local agencies have elected not to conduct their own enforcement.

3. Defines "medical waste" to include, among other things, pharmaceutical waste, which includes a prescription or over-the-counter human or veterinary drug, including, but not limited to, a drug as defined in the Federal Food, Drug, and Cosmetic Act.

4. Requires a person that generates or treats medical waste to ensure that the medical waste is treated by one of the following methods rendering it solid waste:

   1. Incineration at a permitted medical waste treatment facility in a controlled-air, multichamber incinerator, or other method of incineration approved by DPH which provides complete combustion of the waste into carbonized or mineralized ash;

   2. Treatment with an alternative technology approved by DPH that treats the waste with temperatures in excess of 1300 degrees Fahrenheit;

   3. Steam sterilization at a permitted medical waste treatment facility or by other sterilization, in accordance with specified operating procedures for steam sterilizers or other sterilization; or,

   4. Other alternative medical waste treatment methods which are approved by DPH and result in the destruction of pathogenic micro-organisms.

5. Requires any alternative medical waste treatment method to be evaluated by DPH and either approved or rejected pursuant to specified statutory criteria.

6. Prohibits a person from hauling medical waste unless the person is a registered hazardous waste hauler; a mail-back system approved by the United States Postal Service; a common carrier allowed to haul pharmaceutical waste; a small- or large-quantity generator transporting limited quantities of medical waste with an exemption; or a registered trauma scene waste practitioner.

7. Requires pharmaceutical takeback programs to be in compliance with the Controlled Substances Act and its implementing regulations.

8. Regulates air emissions from stationary and mobile sources pursuant to the Federal Clean Air Act.

9. Establishes the California Air Resources Control Board to enforce the Federal Clean Air Act.

This bill:

Allows law enforcement agencies to use approved prescription drug incinerators up to four times per year to treat and dispose of medical waste as specified. Specifically:

1. Amends the MWMA to require any alternative medical waste treatment designed to treat pharmaceutical waste, including a pharmaceutical incinerator, to be evaluated and approved by the Department of Public Health (DPH).

2. Allows a law enforcement agency that operates a prescription drug takeback program to use an approved pharmaceutical incinerator up to four times per year.

Background

1. What is medical waste?: Medical waste is waste materials generated at health care facilities, such as hospitals, clinics, physician's offices, dental practices, blood banks, and veterinary hospitals/clinics, as well as medical research facilities and laboratories. Medical waste includes pharmaceutical waste, including prescription or over-the-counter human or veterinary drugs. Pharmaceuticals were added as covered wastes under the MWMA to transfer management of this waste from the California Department of Toxic Substances Control to the Department of Healthcare Services (now CDPH) in 1996 (SB 1966, Statutes of 1996, Chapter 536).

2. Pharmaceutical takeback programs: According to the U.S. Centers for Medicare & Medicaid Services, approximately $275.9 billion in prescription drugs were predicted to be prescribed in the U.S. in 2014. By 2020, that number is projected to reach $379.9 billion. An estimated 10 to 33% of prescribed medicines are not consumed. With a lack of safe, secure and convenient disposal options, consumers traditionally turn to trashing, flushing or storing these medicines at home.

Over the past several years, Fresno County's takeback program has seen an exponential increase in drug drops offs: the County collected 755 pounds of prescription drugs in Fiscal Year 2011-12; 1,918 pounds in Fiscal Year 2012-13; and 2,457 pounds in Fiscal Year 2013-14. This evidences a growing demand for maintaining a convenient drug takeback program.

Law enforcement-operated takeback systems offer a safe and convenient way for residents to appropriately dispose their expired and unused pharmaceuticals in lieu of flushing or throwing those drugs in the trash can, which is known to cause deleterious impacts to water quality and public health.

3. Pharmaceutical waste treatment: Under current law, pharmaceutical waste can be treated in one of several ways, including:

• Incineration at a permitted medical waste treatment facility;

• Alternative treatment methods that treat the waste with temperatures in excess of 1300 degrees Fahrenheit;

• Steam sterilization at a permitted medical waste treatment facility; or

• Other alternative medical waste treatment methods which are approved by CDPH.

Under the MWMA, pharmaceutical waste must be incinerated and, according to CDPH, there are no permitted incinerators in California for the treatment of that type of medical waste.  (The last medical waste incinerator that was in operation in the state (Integrated Environmental Systems in Oakland) was closed in 2001.)

At this time, all pharmaceutical waste generated from hospitals, pharmacies, retailers, or other generators is shipped by a registered medical waste hauler out of state for treatment.  Permitted in-state facilities treat biohazardous and sharps waste through steam sterilization (autoclaving) or by an approved alternative treatment technology.

Comments

1. Purpose of Bill. According to the author, no permitted medical waste incinerators exist in California, and states, "[w]ith limited options for disposal of these collected pharmaceuticals, law enforcement agencies that operate these takeback programs often resort to expensive methods such as shipping the materials out of state or taking police officers off the street to drive long distances to one of the three California locations where this incineration is permitted.

“AB 649 would permit law enforcement agencies that operate a prescription drug takeback program to use a noncompliant prescription drug incinerator to dispose of the pharmaceuticals they collect from the community.”

2. Amendment needed.

1. Required approval. Amendments added in the June 2, 2015 version of AB 649 state, “By June 1, 2017, the department shall complete the first evaluation and approval of these alternative medical waste treatments, including a pharmaceutical incinerator.” By requiring approval, this language assumes that this technology will meet DPH requirements for public health and environmental safety. An amendment is needed to strike “approval” from this language.

2. Compliance with air quality regulation. While nothing in this legislation provides an exemption from local air quality law or other environmental statute, because this bill amends MWMA, an amendment should be added to clarify that any alternative medical waste treatment evaluated pursuant to this chapter must still meet requirements pursuant to other environmental protection laws.

Related/Prior Legislation

SB 727 (Jackson, 2014) would have: 1) required a producer of a pharmaceutical sold in the state to, individually or through a stewardship organization, to submit a plan, on or before January 1, 2015, to the Department of Resources Recycling and Recovery and 2) required the plan to provide for the development of a program to collect, transport, and process home-generated pharmaceutical drugs and to include specified aspects, including the minimum amount of collection sites, including by January 1, 2016, at least one collection service within 10 miles per person in the state. SB 727 was held by the author in the Senate Business and Professions Committee.

SOURCE:

Author

SUPPORT:

California Health Collaborative

California Police Chiefs Association

California State Sheriff's Association

City of Fresno Police Department

City of Reedley, Police Department

City of Sanger, Police Department

Fresno County Department of Behavioral Health

Valley Children’s Healthcare

OPPOSITION:

None received

-- END --

Date of Hearing: April 29, 2015

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Jimmy Gomez, Chair

ABPCA Bill Id:AB 649

Author:(Patterson) – As Amended Ver:April 16, 2015

Urgency: No State Mandated Local Program: No Reimbursable:

SUMMARY:

This bill allows law enforcement agencies to use approved prescription drug incinerators up to four times per year to treat and dispose of medical waste as specified. Specifically, this bill:

1. Amends the Medical Waste Management Act (MWMA) to require any alternative medical waste treatment designed to treat pharmaceutical waste, including a pharmaceutical incinerator, to be evaluated and approved by the Department of Public Health (DPH).

2. Allows a law enforcement agency that operates a prescription drug takeback program to use an approved pharmaceutical incinerator up to four times per year.

FISCAL EFFECT:

Minor increased costs to DPH (special fund), likely of less than $100,000, to approve alternative medical waste treatments.

COMMENTS:

1. Rationale. Under the MWMA, pharmaceutical waste must be incinerated. According to DPH, there are no incinerators in California permitted for the treatments of this kind of waste. Permitted in-state facilities treat biohazardous and medical sharps waste through steam sterilization (autoclaving) or by an approved alternative treatment technology.

According to the author, law enforcement personnel administrating takeback programs are currently hauling or shipping their wastes to one of three federally compliant Large Municipal Waste Combustor (LMWC) or Standards and Small Municipal Waste Combustor (SMWC) of which there are three in California: 1) Commerce Refuse-to-Energy Facility (Commerce); 2) Southeast Resource Recovery Facility (Long Beach); and 3) Stanislaus County Resource Recovery Facility (Crow’s Landing). However, none of these facilities are permitted under the MWMA to treat pharmaceutical waste.

This bill allows a law enforcement agency that operates a prescription drug takeback program to use an alternative medical waste treatment, including a pharmaceutical incinerator, up to four times per year to treat and dispose of medical waste.

2. Background. The United States Environmental Protection Agency (US EPA) issued a guidance letter on September 2012 on the disposal of household pharmaceuticals collected by takeback programs. The letter recommended pharmaceutical waste be sent to a permitted hazardous waste combustor, and, when that is not feasible, be sent to a large or small municipal combustor. The US EPA also acknowledges that it does not want [incineration] costs to discourage takeback events and subsequently recommended incineration facilities that meet the US EPA's Large Municipal Waste Combustor (LMWC) Standards and Small Municipal Waste Combustor (SMWC) Standards when hazardous waste combustion is not feasible.

3. Pharmaceutical Waste. Pharmaceutical waste is segregated into three different categories for proper treatment: controlled, hazardous, and non-hazardous.

Drugs and other substances that are considered controlled substances under the federal Controlled Substances Act (CSA) are categorized based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused.  These pharmaceuticals are managed differently than hazardous and non-hazardous pharmaceuticals; controlled substances must be disposed of in a manner that renders them non-retrievable in accordance with federal regulations, unlike the other categories of pharmaceutical waste.

4. Federal Programs. The Drug Enforcement Administration (DEA) hosts National Prescription Drug Takeback Days to provide opportunities for disposing controlled substances. To date, the DEA has held 9 takeback days, with the most recent event held in September 2014. The DEA initiated these takeback days four years ago because at that time the CSA made no legal provision for people to dispose of unwanted controlled substance prescription drugs except to give them to law enforcement, and the CSA banned pharmacies and hospitals from accepting them. 

Since the DEA’s first Takeback Day, the DEA has developed regulations that outline methods the public can use to transfer pharmaceutical controlled substances and other prescription drugs to authorized collectors for the purpose of disposal. 

The DEA has announced it plans to cease holding its takeback days because the new disposal regulations are registered and in effect for disposing controlled substances.   According to the DEA, law enforcement continues to have autonomy with respect to how they collect controlled substance prescription drugs, including holding takeback events.  Any person or entity—DEA registrant or non-registrant—may partner with law enforcement to conduct takeback events. 

Analysis Prepared by: Jennifer Galehouse / APPR. / (916) 319-2081

Date of Hearing: April 14, 2015

ASSEMBLY COMMITTEE ON ENVIRONMENTAL SAFETY AND TOXIC MATERIALS

Alejo, Chair

ABPCA Bill Id:AB 649

Author:(Patterson) – As Introduced Ver:February 24, 2015

SUBJECT:

Medical waste: law enforcement drug takeback programs

SUMMARY:

Authorizes law enforcement agencies to use prescription drug incinerators not in compliance with various state laws up to four times. Specifically, this bill:

Amends the Medical Waste Management Act (MWMA) to allow a law enforcement agency that operates a prescription drug takeback program to utilize up to four times per year a prescription drug incinerator that does not comply with the requirements of the MWMA or other state laws if the incinerator was purchased prior to January 1, 2018.

EXISTING LAW:

1. Exempts household pharmaceutical waste from hazardous waste classifications (40 CFR 261.4(b)) and as medical waste. (Health and Safety Code (H&S) § 117700)

2. Pursuant to the MWMA, requires the California Department of Public Health (CDPH) to regulate the management and handling of medical waste and authorizes off-site medical waste treatment facilities, oversees transfer stations, approves alternative treatment technologies, and acts as the local enforcement agency in 25 jurisdictions where local agencies have elected not to conduct their own enforcement. (H&S § 117600, et seq.)

3. Defines "medical waste" to include, among other things, pharmaceutical waste, which includes a prescription or over-the-counter human or veterinary drug, including, but not limited to, a drug as defined in the Federal Food, Drug, and Cosmetic Act. (H&S § 117690 and § 117747)

4. Requires a person that generates or treats medical waste to ensure that the medical waste is treated by one of the following methods rendering it solid waste:

   1. Incineration at a permitted medical waste treatment facility in a controlled-air, multichamber incinerator, or other method of incineration approved by CDPH which provides complete combustion of the waste into carbonized or mineralized ash;

   2. Treatment with an alternative technology approved by CDPH that treats the waste with temperatures in excess of 1300 degrees Fahrenheit;

   3. Steam sterilization at a permitted medical waste treatment facility or by other sterilization, in accordance with specified operating procedures for steam sterilizers or other sterilization; or,

   4. Other alternative medical waste treatment methods which are approved by CDPH and result in the destruction of pathogenic micro-organisms. (H&S § 118215(a))

5. Requires any alternative medical waste treatment method to be evaluated by CDPH and either approved or rejected pursuant to specified statutory criteria. (H&S § 118215 (a)(1)(B))

6. Prohibits a person from hauling medical waste unless the person is a registered hazardous waste hauler; a mail-back system approved by the United States Postal Service; a common carrier allowed to haul pharmaceutical waste; a small- or large-quantity generator transporting limited quantities of medical waste with an exemption; or a registered trauma scene waste practitioner. (H&S § 117900)

7. Requires pharmaceutical takeback programs to be in compliance with the Controlled Substances Act and its implementing regulations. (21 U.S.C. § 801-971 and 21 CFR 1300-1321)

8. Regulates air emissions from stationary and mobile sources pursuant to the Federal Clean Air Act. (42 U.S.C. §7401 et seq.)

9. Establishes the California Air Resources Control Board to enforce the Federal Clean Air Act. (H&S 39500 § et seq.)

FISCAL EFFECT:

Unknown.

COMMENTS:

Purpose for reform: According to the author, no permitted medical waste incinerators exist in California, and states, "[w]ith limited options for disposal of these collected pharmaceuticals, law enforcement agencies that operate these takeback programs often resort to expensive methods such as shipping the materials out of state or taking police officers off the street to drive long distances to one of the three California locations where this incineration is permitted.

"AB 649 would permit law enforcement agencies that operate a prescription drug takeback program to use a noncompliant prescription drug incinerator to dispose of the pharmaceuticals they collect from the community."

What is medical waste?: Medical waste is waste materials generated at health care facilities, such as hospitals, clinics, physician's offices, dental practices, blood banks, and veterinary hospitals/clinics, as well as medical research facilities and laboratories. Medical waste includes pharmaceutical waste, including prescription or over-the-counter human or veterinary drugs. Pharmaceuticals were added as covered wastes under the MWMA to transfer management of this waste from the California Department of Toxic Substances Control to the Department of Healthcare Services (now CDPH) in 1996 (SB 1966 (Statutes of 1996, Chapter 536)).

Pharmaceutical takeback programs: According to the U.S. Centers for Medicare & Medicaid Services, approximately $275.9 billion in prescription drugs were predicted to be prescribed in the U.S. in 2014. By 2020, that number is projected to reach $379.9 billion. An estimated 10 to 33 percent of prescribed medicines are not consumed. With a lack of safe, secure and convenient disposal options, consumers traditionally turn to trashing, flushing or storing these medicines at home.

Over the past several years, Fresno County's takeback program has seen an exponential increase in drug drops offs: the County collected 755 pounds of prescription drugs in Fiscal Year 2011-2012; 1,918 pounds in Fiscal Year 2012-2013; and 2,457 pounds in Fiscal Year 2013-2014. This evidences a growing demand for maintaining a convenient drug takeback program.

Law enforcement-operated takeback systems offer a safe and convenient way for residents to appropriately dispose their expired and unused pharmaceuticals in lieu of flushing or throwing those drugs in the trash can, which is known to cause deleterious impacts to water quality and public health.

Pharmaceutical waste treatment: Under current law, pharmaceutical waste can be treated in one of several ways, including:

• Incineration at a permitted medical waste treatment facility;

• Alternative treatment methods that treat the waste with temperatures in excess of 1300 degrees Fahrenheit;

• Steam sterilization at a permitted medical waste treatment facility; or

• Other alternative medical waste treatment methods which are approved by CDPH.

Under the MWMA, pharmaceutical waste must be incinerated and, according to CDPH, there are no permitted incinerators in California for the treatment of that type of medical waste.  (The last medical waste incinerator that was in operation in the state (Integrated Environmental Systems in Oakland) was closed in 2001.)

At this time, all pharmaceutical waste generated from hospitals, pharmacies, retailers, or other generators is shipped by a registered medical waste hauler out of state for treatment.  Permitted in-state facilities treat biohazardous and sharps waste through steam sterilization (autoclaving) or by an approved alternative treatment technology.

What does this bill authorize, exactly?: The bill would allow a law enforcement agency that operates a prescription drug takeback program to use a prescription drug incinerator that does not comply with the requirements of the MWMA or other state laws if the incinerator was purchased prior to January 1, 2018.

The United States Environmental Protection Agency (US EPA), in a September 2012 guidance letter on the disposal of household pharmaceuticals collected by takeback programs, recommended that pharmaceutical waste be sent to a permitted hazardous waste combustor, and, when that is not feasible, be sent to a large or small municipal combustor. The US EPA specifically states, "after pharmaceuticals are collected from ultimate users in a takeback event, they must be disposed of in accordance with federal, state and/or local environmental regulations."

The US EPA also acknowledges that it does "not want [incineration] costs to discourage takeback events", and subsequently recommended incineration facilities that meet the US EPA's Large Municipal Waste Combustor (LMWC) Standards and Small Municipal Waste Combustor (SMWC) Standards (40 CFR parts 62 and 60) when hazardous waste combustion is not feasible.

According to the author, law enforcement personnel administrating takeback programs are currently hauling or shipping their wastes to one of three federally compliant LMWC or SMWC, of which there are three in California:

• Commerce Refuse-to-Energy Facility (Commerce)

• Southeast Resource Recovery Facility (Long Beach)

• Stanislaus County Resource Recovery Facility (Crow’s Landing)

None of these facilities, however, are permitted under the MWMA to treat pharmaceutical waste.

Therefore, this bill would authorize a broader scope of options for pharmaceutical incineration. The bill does not contain a definition for "prescription drug incinerator," so the bill could potentially apply to any incinerator that is or could be permitted to take prescription drugs.

One cited example of a noncompliant incinerator this bill could authorize is the "Drug Terminator", which is described as a wood or charcoal fired incinerator that uses two high velocity electric blowers that create a cyclone of intense heat, and render the volume of material as solid waste.

The MWMA requires incineration to be done at a “permitted medical waste treatment facility in a controlled-air, multi-chamber incinerator, or other method of incineration approved by the Department.” It's not yet determined if the "Drug Terminator" would qualify as an acceptable treatment method in California, but under current law, it is eligible to be considered as an alternative medical waste treatment method. (H&S § 118215 (a)(3)(A))

Managing pharmaceutical waste: Pharmaceutical waste is segregated into three different categories for proper treatment: controlled, hazardous, and non-hazardous.

Drugs and other substances that are considered controlled substances under the federal Controlled Substances Act (CSA) are categorized based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused.  These pharmaceuticals are managed differently than hazardous and non-hazardous pharmaceuticals; controlled substances must be disposed of in a manner that renders them non-retrievable in accordance with federal regulations, unlike the other categories of pharmaceutical waste.

The Drug Enforcement Administration (DEA) hosts National Prescription Drug Takeback Days to provide opportunity for disposing controlled substances. To date, the DEA has held 9 takeback days, with the most recent event held in September 2014. The DEA initiated these takeback days four years ago because at that time the CSA made no legal provision for people to dispose of unwanted controlled substance prescription drugs except to give them to law enforcement, and the CSA banned pharmacies and hospitals from accepting them. 

Since the DEA’s first Takeback Day, the DEA has developed regulations that outline methods the public can use to transfer pharmaceutical controlled substances and other prescription drugs to authorized collectors for the purpose of disposal. 

The DEA has announced it plans to cease holding its takeback days because the new disposal regulations are registered and in effect for disposing controlled substances.   According to the DEA, law enforcement continues to have autonomy with respect to how they collect controlled substance prescription drugs, including holding takeback events.  Any person or entity—DEA registrant or non-registrant—may partner with law enforcement to conduct takeback events. 

Alternatives for managing pharmaceutical waste over the status quo: There are registered medical waste haulers in California that pick up medical waste and transport to permitted medical waste treatment facilities. There are currently 125 medical waste transporters registered under the MWMA. In addition, there are numerous transfer stations in California that are part of the medical waste disposal chain.  These transfer stations serve as the collection and consolidation points for all types of medical waste.  The waste is further segregated at this point and shipped to the proper treatment facilities (either in or out of state).

Registered haulers can pick up and transport hazardous and non-hazardous pharamcetuicals wastes. According to one registered medical waste hauler, average costs to provide pharmaceutical waste pick-up services to a law enforcement agency would range from $60-$110/hour for a pharmaceutical technician to sort through the collected pharmaceuticals and segregate categorically for disposal, and then $1-$3/pound for disposal.

Depending on law enforcement agencies' current costs, they could consider the costs to hire a registered medical waste hauler to periodically pick up the agency's collected pharmaceuticals versus shipping or transporting their collected pharmaceutical wastes themselves. While potentially more expensive, this alternative to managing pharmaceutical waste may be more advantageous from a public health perspective than changing state law to allow noncompliant incinerators.

Proposed amendments: As written, the bill may be overly broad in allowing incinerators that don’t comply with various environmental protection and medical waste management laws. To maintain the author's intent to authorize more in-state options for treating pharmaceutical waste, and to ensure pharmaceutical wastes are appropriately destroyed, the committee may wish to consider the following amendments:

1. Striking lines 1-2 on page 2 in reference to noncompliant incinerators, and replacing with language authorizing CDPH to approve and permit under the MWMA prescription drug incinerators designed to treat pharmaceutical waste as an alternative medical waste treatment method; and

2. Amending the MWMA to authorize CDPH to permit prescription drug incinerators that are specifically designed to solely treat pharmaceutical wastes and that meet any necessary requirements for safely treating those wastes.

Related legislation:

AB 45 (Mullin), pending before the Assembly Local Government Committee, would establish household hazardous waste collection programs and would include collection of household generated pharmaceutical waste.

REGISTERED SUPPORT / OPPOSITION:

Support

California Health Collaborative

California State Sheriff's Association

Fresno County Department of Behavioral Health

Opposition

None on file.

Analysis Prepared by:

Paige Brokaw / E.S. & T.M. / (916) 319-3965